Milestone Guide
- Jurgen Wanke
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Milestone Category |
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Target - Timeline for Implementation |
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Actual - Timeline for Implementation |
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Resource/ Tool |
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1.0 |
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SBR Charter |
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1.1 |
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Define the scope of research within the SBR. |
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Aug-07 |
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Aug-07 |
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SBR Charter Template |
1.2 |
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Identify the key personnel (i.e. Faculty Leader, Lead Study Coordinator, Financial Manager, Other). |
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Aug-07 |
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Aug-07 |
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1.2.1 |
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If applicable, consult with CRSO leadership regarding any job duties/responsibilities which are in addition to the standard key personnel job descriptions developed by the CRSO. |
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Aug-07 |
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Aug-07 |
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1.2.2 |
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Identify the Faculty Leader. |
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Aug-07 |
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Aug-07 |
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1.2.3 |
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Identify the Lead Study Coordinator. |
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Aug-07 |
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Aug-07 |
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1.2.4 |
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Identify the Financial Manager. |
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Aug-07 |
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Aug-07 |
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1.2.5 |
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Identify other key SBR personnel. |
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Aug-07 |
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Aug-07 |
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1.3 |
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Define clusters and leadership within the clusters. |
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Aug-07 |
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Aug-07 |
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1.4 |
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Define the composition and function of the Faculty Advisory Board. |
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Aug-07 |
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Aug-07 |
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1.5 |
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Describe who the SBR reports to (to whom the SBR is ultimately accountable) and which organization(s) provide the backstop for the SBR. |
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Aug-07 |
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Aug-07 |
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1.6 |
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List the SBR Stakeholders, which could include clinical departments, centers, institutes and CSUs. |
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Aug-07 |
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Aug-07 |
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1.7 |
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Develop a communication plan for keeping faculty and staff abreast of institutional direction as well as SBR initiatives and organization. |
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Aug-07 |
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Aug-07 |
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2.0 |
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Personnel Management |
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2.1 |
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Identify the SBR leadership responsible for making staff hiring decisions. |
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Sep-07 |
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Sep-07 |
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2.2 |
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Identify the SBR leadership responsible for new staff orientation. |
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Sep-07 |
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Sep-07 |
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New Hire Orientation Checklist |
2.3 |
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Determine and document process for assessing workload, identifying staffing needs and assigning staff to studies. |
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Jan-08 |
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2.4 |
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Create (and maintain) master list of which staff are assigned to which study and identify individual responsible for maintaining the list. |
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Jan-08 |
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2.5 |
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Create list of SBR coordinators and research staff and maintain listing on CRSO website. Identify SBR staff responsible for updating the list. |
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Jan-08 |
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SBR Clinical Staff Template |
2.6 |
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Create list of SBR financial staff and maintain listing on CRSO website. Identify SBR staff responsible for updating the list. |
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Jan-08 |
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SBR Financial Staff Template |
2.7 |
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Create (and maintain) research training records for all staff. |
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Jan-08 |
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Training Record Checklist |
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3.0 |
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Communication Plan |
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3.1 |
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Develop communication plan to keep faculty and staff abreast of institutional direction and SBR initiatives and organization. |
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Aug-07 |
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Aug-07 |
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SBR Charter |
3.2 |
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Develop communication mechanism to represent faculty/staff needs to Advisory Council. |
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Aug-07 |
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Aug-07 |
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3.3 |
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Determine mode of communication with principal investigators and research staff (i.e. meetings, emails, newsletters). |
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Aug-07 |
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Aug-07 |
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3.4 |
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Determine frequency of communications. |
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Aug-07 |
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Aug-07 |
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3.5 |
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Develop communication expectations within SBRU leadership between Medical Director, Lead Study Coordinator and Financial Manager. |
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Nov-07 |
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Nov-07 |
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4.0 |
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Financial Management |
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4.1 |
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Prepare listing of all studies in the SBR and identify who will be responsible for maintaining the list. |
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Jan-08 |
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Study Listing Template |
4.2 |
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Determine and document allocation method for faculty and staff salary and fringe assignment. |
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Aug-07 |
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Aug-07 |
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Examples of Time Tracking Systems and Activities |
4.3 |
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Identify SBR staff responsible for preparation of sponsor invoices. |
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Aug-07 |
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Aug-07 |
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SBR Sponsor Invoice Form |
4.4 |
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Determine SBR administrative allocation. |
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Aug-07 |
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Aug-07 |
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Diagram B - Post Award Functionality |
4.5 |
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Prepare a study-specific cash flow report for each study. |
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Mar-08 |
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Cash Flow Template |
4.6 |
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Prepare a study-specific profit/loss report for each study. |
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Mar-08 |
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Study Profit and Loss Template |
4.7 |
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Implement study close-out form. |
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Mar-08 |
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Study Close-out Form |
4.8 |
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Determine responsibility for reconciliation and progress reporting of all studies. |
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Mar-08 |
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4.9 |
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Define check deposit procedures and reconciliation in accordance with School of Medicine and University policies. |
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Aug-07 |
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Aug-07 |
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4.10 |
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Define milestone payment notification process within SBRU. |
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Mar-08 |
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4.11 |
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Determine responsibility for SPS entry of all studies. |
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Aug-07 |
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Aug-07 |
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5.0 |
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Overall Financial Accountability for the SBR |
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5.1 |
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Prepare an aggregated profit and loss report on a monthly basis for the overall financial performance of the SBR that encompasses all infrastructure costs as well as study-specific expenses and revenues. |
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Mar-08 |
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SBR Profit and Loss Template |
5.2 |
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Prepare an aggregated accounts receivable report on a monthly basis across all studies. |
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Mar-08 |
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Account Receivable Tool |
5.3 |
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Determine responsibility for analysis and distribution of reports. |
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Mar-08 |
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SBR Profit and Loss Template |
5.4 |
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Negotiate any MOU's with other SBRs, as needed. |
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Mar-08 |
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MOU Template |
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6.0 |
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Billing Activities |
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6.1 |
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Completion of all fields in the IDX Dictionary 703 for all current projects. |
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Jan-07 |
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6.2 |
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Identify the SBR staff who will be responsible for communicating IDX Dictionary 703 updates to the CRSO. |
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Jan-07 |
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7.0 |
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Study Evaluation and Selection Process |
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7.1 |
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Develop the criteria for study evaluation and selection and post to SBR website. |
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Mar-08 |
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Protocol Feasibility Tool |
7.2 |
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Develop the process for study evaluation and selection and post to SBR website. |
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Mar-08 |
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7.3 |
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Determine and document process for review and assessment of protocol feasibility (clinical, financial, IND/IDE, etc) for each study. |
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Mar-08 |
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7.4 |
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Determine and document a sign-off process for new study submissions. |
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Mar-08 |
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8.0 |
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Study Initiation |
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8.1 |
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Contract Negotiation |
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8.1.1 |
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Identify the SBR staff who will serve as point-person(s) and respond to inquiries and contract questions. |
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Aug-07 |
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Aug-07 |
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Budget Template Tool |
8.1.2 |
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Identify the SBR staff who will have the authority to provide approval on behalf of the SBR for contract language. |
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?? |
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8.2 |
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IRB Preparation and Submission |
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Start-up Project Checklist |
8.2.1 |
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Identify the SBR staff responsible for IRB preparation and submission. |
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Aug-07 |
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Aug-07 |
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8.3 |
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Budget Development |
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8.3.1 |
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Identify the SBR staff who will develop the study budget. |
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Aug-07 |
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Aug-07 |
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8.3.2 |
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Implement use of standard budget template. |
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Mar-08 |
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8.3.3 |
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Determine who in the SBRU approves all study budgets. |
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Mar-08 |
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8.4 |
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Charge Assignment Grid Development |
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8.4.1 |
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Identify the SBR staff responsible for the development of charge assignment grids. |
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Aug-07 |
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Aug-07 |
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8.4.2 |
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Identify the SBR staff who will review the charge assignment grid against the study budget, schedule of events, contract, and then provide ultimate approval. |
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Aug-07 |
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Aug-07 |
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9.0 |
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Study Conduct |
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Standards under development and will be adopted in Fall 2007. Training to be provided after standards are adopted. |
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10.0 |
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IND/IDEÂ |
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10.1 |
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Create list of IND/IDE projects. |
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Nov-07 |
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Nov-07 |
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10.2 |
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Maintain list of IND/IDE projects. |
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Nov-07 |
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Nov-07 |
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10.3 |
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Assign who will be responsible for updating the IND/IDE listing of projects. |
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Nov-07 |
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Nov-07 |
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11.0 |
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Quality Control |
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11.1 |
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Develop quality control plan. |
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May-08 |
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Quality Control Plan Template |
11.2 |
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Identify the SBR staff who will be responsible for conducting the review of training records on a periodic basis. |
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Nov-07 |
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Nov-07 |
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11.3 |
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Identify the SBR staff who will be responsible for reviewing and responding to the audits conducted by the Compliance Offices. |
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Nov-07 |
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Nov-07 |
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11.4 |
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Identify the SBR staff who will be responsible for implementing the corrective action plan proposed by the Compliance Offices. |
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Nov-07 |
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Nov-07 |
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12.0 |
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Annual Report |
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12.1 |
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Prepare an annual report that will include the following information: |
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Annual Report Template |
12.1.1 |
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Number of studies. |
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Dec-08 |
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12.1.2 |
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Number of subjects enrolled. |
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Dec-08 |
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12.1.3 |
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Demographic profile of study subjects. |
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Dec-08 |
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12.1.4 |
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List of publications resulting from work within the SBR. List should be sorted as follows: |
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12.1.4.1 |
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Studies where the SBR was the sole or lead site |
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Dec-08 |
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12.1.4.2 |
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Studies where the faculty member was listed on the masterhead. |
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Dec-08 |
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12.1.4.3 |
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Studies where the only role of the group was to enroll patients in a multi-center study based elsewhere. |
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Dec-08 |
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12.1.5 |
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Provide explanation for those studies which do not lead to publication or other public disclosure of results. |
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Dec-08 |
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12.2 |
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Identify SBR personnel to maintain listing of publications. |
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Dec-08 |
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12.3 |
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Assess satisfaction of faculty and staff. |
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Dec-08 |
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Web-Based Satisfaction Survey |
12.4 |
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Review and re-evaluate SBR processes as needed. |
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Dec-08 |
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12.5 |
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Prepare a year-end financial report. |
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Dec-08 |
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Milestone Category is a component of the Site-Based Research Charter |
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Resource tool under development |
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